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FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Classification update

FDA have updated their classification codes for devices intended: To detect and identify nucleic acid targets including SARS-CoV-2 in respiratory specimens (Class II with special controls), To detect and identify selected microbial agents that cause acute febrile illness (Class II with special controls)
Ben Kemp
August 20, 2024